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Guidance

Investigational New Drug

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application.

  • Pre-IND consultation program (HTML)
  • Information on Submitting an Investigational New Drug Application (HTML)
  • Vaccine Approval Process (HTML)

 

Regulatory Submissions in Electronic Format

Regulatory Submissions in Electronic Format are extensive requirements in the Code of Federal Regulations (CFR) regarding the information that needs to be submitted in order to seek approval to begin clinical testing of a biologic product and to market a biologic product. FDA has started the transition to a more automated electronic review process for these submissions.

 

Emergency Use Authorization

The Emergency Use Authorization (EUA) authority allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological, and nuclear agents that may be used to attack the American people or the U.S. armed forces. Under section 564, the FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved, and available alternatives.

  • FDA Extends Authorization for Emergency Use of Anthrax Vaccine (July 22, 2005) (HTML)
  • Authorization of Emergency Use of Anthrax Vaccine (January 31, 2005) (PDF - 1.38 MB)*
  • Administrative Procedures for Emergency Use Authorization of Medical Products (SOPP 8010). (August 3, 2005). (HTML)

 

Select Agent Rule (42 CFR Parts 72 & 73)

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 provides for the regulation of certain biological agency and toxins by the Department of Health and Human Services and the Department of Agriculture. For the Department of Health and Human Services, CDC has been designated as the agency with the primary responsibility for implementing the provisions of this Act.

  • Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins. Final rule. (March 18, 2005)
  • Possession, Use, and Transfer of Select Agents and Toxins. Final rule. (March 18, 2005) (PDF - 254 KB)
  • Laboratory security and emergency response guidance for laboratories working with select agents. MMWR Morbidity and Mortality Weekly Rep. 2002 Dec 6;49(RR-19):1-6. (HTML)

 

Animal Efficacy Rule

Animal Efficacy Rule: The Food and Drug Administration (FDA) has amended its new drug and biological product regulations to allow appropriate studies in animals in certain cases to provide substantial evidence of the effectiveness of new drug and biological products used to reduce or prevent the toxicity of chemical, biological, radiological, or nuclear substances. This rule will apply when adequate and well-controlled clinical studies in humans cannot be ethically conducted and field efficacy studies are not feasible. In these situations, certain new drug and biological products that are intended to reduce or prevent serious or life-threatening conditions may be approved for marketing based on evidence of effectiveness derived from appropriate studies in animals and any additional supporting data.

FDA has issued Guidance for Industry regarding Product Development Under the Animal Rule. This guidance focuses on the identification of the critical characteristics (essential data elements) of an animal model to be addressed when developing drug or biological products for approval or licensure, respectively, under the 'Animal Rule'. (See 21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products.)

 

Technology Readiness Levels (TRLs)

 

Guidance Regarding Specific Types of Medical Countermeasures

  • CDER DRAFT Guidance: Inhalational Anthrax (Post-Exposure) - Developing Antimicrobial drugs. March 2002. (PDF)
  • CDER DRAFT Guidance: Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination. March 2004. (PDF - 138 KB)
  • CDER Guidance: Internal Radioactive Contamination-Development of Decorporation Agents FINAL Guidance. March 2006. (PDF)
  • Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (HTML)
  • Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines (HTML)
  • Use of Masks During a Pandemic (HTML)
  • Personal Protective Equipment and Patient Care (HTML)

 

Acquisition Regulations

  • Federal Acquisition Regulations (FAR)The Federal Acquisition Regulations System is established for the codification and publication of uniform policies and procedures for acquisition by all executive agencies. The Federal Acquisition Regulations System consists of the Federal Acquisition Regulation (FAR), which is the primary document, and agency acquisition regulations that implement or supplement the FAR. The FAR System does not include internal agency guidance of the type described in 1.301(a)(2).
  • HHS Acquisition Regulation (HHSAR)The Department of Health and Human Services Acquisition Regulation (HHSAR) is issued to establish uniform acquisition policies and procedures for the Department of Health and Human Services (HHS) which conform to the Federal Acquisition Regulation (FAR) System. The HHSAR implements and supplements the FAR. (Implementing material expands upon or indicates the manner of compliance with related FAR material. Supplementing material is new material which has no counterpart in the FAR.) The HHSAR contains all formal departmental policies and procedures that govern the acquisition process or otherwise control contracting relationships between the Department 's contracting offices and contractors.